§79.51. General requirements and provisions.

All manufacturers of fuels and fuel additives that are designated for registration under this part are required to comply with the requirements of subpart F of this part either on an individual basis or as a participant in a group of manufacturers of the same or similar fuels and fuel additives, as defined in § 79.56. If manufacturers elect to comply by participation in a group, each manufacturer continues to be individually subject to the requirements of subpart F of this part, and responsible for testing under this subpart. Each manufacturer, subject to the provisions for group applications in § 79.51(b) and the special provisions in § 79.58, shall submit all Tier 1 and Tier 2 information required by §§ 79.52, 79.53 and 79.59 for each fuel or additive, except that the Tier 1 emission characterization requirements in § 79.52(b) and/or the Tier 2 testing requirements in § 79.53 may be satisfied by adequate existing information pursuant to the Tier 1 literature search requirements in § 79.52(d). The adequacy of existing information to serve in compliance with specific Tier 1 and/or Tier 2 requirements shall be determined according to the criteria and procedures specified in §§ 79.52(b) and 79.53 (c) and (d). In all cases, EPA reserves the right to require, based upon the information contained in the application or any other information available to the Agency, that manufacturers conduct additional testing of any fuel or additive (or fuel/additive group) if EPA determines that there is inadequate information upon which to base regulatory decisions for such product(s). In any case where EPA determines that the requirements of Tiers 1 and 2 have been satisfied but that further testing is required, the provisions of Tier 3 (§ 79.54) shall apply.

Laboratory facilities shall perform testing in compliance with Good Laboratory Practice (GLP) requirements as those requirements apply to inhalation toxicology studies. All studies shall be monitored by the facilities' Quality Assurance units (as specified in § 79.60).

A testing facility, whether engaged in emissions analysis or health and/or welfare effects testing under the regulations in this subpart, shall permit an authorized employee or duly designated representative of EPA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this subpart applies. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except the EPA may seek production of these records in litigation or informal hearings.

EPA will not consider reliable for purposes of showing that a test substance does or does not present a risk of injury to health or the environment any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this section. The determination that a study will not be considered reliable does not, however, relieve the sponsor of a required test of any obligation under any applicable statute or regulation to submit the results of the study to EPA.

Effects of non-compliance. Pursuant to sections 114, 208, and 211(d) of the CAA, it shall be a violation of this section and a violation of 40 CFR part 79, subpart F to deny entry to an authorized employee or duly designated representative of EPA for the purpose of auditing a testing facility or test data.

Any person who violates these regulations shall be subject to a civil penalty of up to $25,000 for each and every day of the continuance of the violation and the economic benefit or savings resulting from the violation. Action to collect such civil penalties shall be commenced in accordance with paragraph (b) of section 205 of the Clean Air Act or assessed in accordance with paragraph (c) of section 205 of the Clean Air Act, 42 U.S.C. 7524 (b) and (c).

Under section 205(b) of the CAA, the Administrator may commence a civil action for violation of this subpart in the district court of the United States for the district in which the violation is alleged to have occurred or in which the defendant resides or has a principal place of business.

Under section 205(c) of the CAA, the Administrator may assess a civil penalty of $25,000 for each and every day of the continuance of the violation and the economic benefit or savings resulting from the violation, except that the maximum penalty assessment shall not exceed $200,000, unless the Administrator and the Attorney General jointly determine that a matter involving a larger penalty amount is appropriate for administrative penalty assessment. Any such determination by the Administrator and the Attorney General shall not be subject to judicial review.

The Administrator may, upon application by the person against whom any such penalty has been assessed, remit or mitigate, with or without conditions, any such penalty.

The district courts of the United States shall have jurisdiction to compel the furnishing of information and the conduct of tests required by the Administrator under these regulations and to award other appropriate relief. Actions to compel such actions shall be brought by and in the name of the United States. In any such action, subpoenas for witnesses who are required to attend a district court in any district may run into any other district.

The civil monetary penalty amounts listed in this section may not reflect recent inflation adjustments EPA is required to make. The current maximum and minimum statutory civil penalty amounts are located in § 19.4.

In special circumstances, a manufacturer subject to the registration requirements of this rule may petition the Administrator to modify the mandatory testing requirements in the test standard for any test required by this rule by application to Director, Field Operations and Support Division, at the address in paragraph (f)(6)(iii) of this section.

[Reserved]

When the composition information reported in the registration application or basic registration data for a gasoline or diesel product meets criteria for classification as a non-baseline product (pursuant to § 79.56(e)(3)(i)(B) or § 79.56(e)(3)(ii)(B)), then the manufacturer is responsible for testing (or participating in group testing) of a separate formulation for each reported oxygenating compound, specified class of oxygenating compounds, or other substance which defines a separate non-baseline fuel/additive group pursuant to § 79.56(e)(4)(ii)(A) or (B). For each such substance, testing shall be performed on a mixture of the relevant substance in the appropriate base fuel, formulated according to the specifications for the corresponding group representatives in § 79.56(e)(4)(ii).

When the composition information reported in the registration application or basic registration data for a non- baseline gasoline product contains a range of total oxygenate concentration-in-use which encompasses gasoline formulations with less than 1.5 weight percent oxygen as well as gasoline formulations with 1.5 weight percent oxygen or more, then the manufacturer is required to test (or participate in applicable group testing of) a baseline gasoline formulation as well as one or more non-baseline gasoline formulations as described in paragraph (h)(1) of this section.

When the composition information reported in the registration application or basic registration data for a non- baseline diesel product contains a range of total oxygenate concentration-in-use which encompasses diesel formulations with less than 1.0 weight percent oxygen as well as diesel formulations with 1.0 weight percent oxygen or more, then the manufacturer is required to test (or participate in applicable group testing) of a baseline diesel formulation as well as one or more non-baseline diesel formulations as described in paragraph (h)(1) of this section.

The presence in a particular oxygenating additive of small amounts of other unintended oxygenate compounds as byproducts of the manufacturing process of the given oxygenating additive does not affect the grouping of that additive and does not create multiple testing responsibilities for manufacturers who blend that additive into fuel.